|Publication number||US7192414 B2|
|Application number||US 11/023,931|
|Publication date||Mar 20, 2007|
|Filing date||Dec 28, 2004|
|Priority date||Apr 18, 2001|
|Also published as||US7083593, US20020156462, US20050113745|
|Publication number||023931, 11023931, US 7192414 B2, US 7192414B2, US-B2-7192414, US7192414 B2, US7192414B2|
|Inventors||Mark R Stultz|
|Original Assignee||Advanced Bionics Corporation|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (20), Referenced by (6), Classifications (18), Legal Events (8)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present application is a continuation of U.S. patent application Ser. No. 10/099,060, filed Mar. 15, 2002, now U.S. Pat. No. 7,083,593, which application claims the benefit of U.S. Provisional Application Ser. No. 60/284,771, filed Apr. 18, 2001. Both applications are herein incorporated by reference in their entireties.
The present invention relates to implantable medical devices, and more particularly to an implantable programmable pump having multiple reservoirs and a multiple lumen catheter through which independent medications may be delivered to a patient at programmed times or upon demand.
Patients typically require short bursts of independent medications delivered at unique times. Such medications, or drugs, may be delivered via independently accessed reservoirs or may be bolused on demand via a suitable controller. Patients experiencing pain, and receiving medication therefor, may require a short acting, independently-delivered, analgesic rather than an incremental bolus of an admixture or of morphine alone. Spasticity patients may require a burst of pain medications in addition to anti-spasticity medications, or another drug to temporarily increase tone during patient transfers, or other critical times. For example, a cocktail mixture of pain medication in conjunction with another drug that counteracts baclofen for a short period of time may also assist in patient transfers, or other critical times when the patient's muscles require increased tone.
U.S. Pat. No. 4,588,394 teaches a totally subcutaneously implantable infusion reservoir and pump system that includes a variable capacity reservoir for receiving and storing fluids containing medications for delivery to a catheter, which catheter directs the medications to a specific infusion location in the body. A pump and valving arrangement is interposed between the reservoir and the catheter to facilitate and control the transfer of the medications from the reservoir to the catheter in a safe and efficient manner. There is no provision for the delivery of multiple medications through the same catheter.
U.S. Pat. No. 4,449,983 discloses an osmotic device that delivers two beneficial drugs to an environment of use. The device comprises a wall surrounding a lumen divided into a first compartment containing a drug that is separated by a hydrogel partition from a second compartment containing a different drug. An orifice through the wall communicates with the first compartment for delivering drug formulation from the first compartment, and another orifice through the wall communicates with the second compartment for delivering drug formulation from the second compartment. In use, drug formulation is dispensed separately from each compartment by fluid being imbibed through the wall of the device into each compartment at a rate controlled by the permeability of the wall and the osmotic pressure gradient across the wall against the drug formulation in each compartment. A solution is thus produced in each compartment containing drugs. Through the expansion and swelling of the hydrogel, the drug formulation is dispensed through the respective orifices at a controlled and continuous rate over a prolonged period to time. There is no provision for bolus drug delivery over a short period of time, or for programmed rates of delivery.
U.S. Pat. No. 5,240,713 teaches a dual rate agent delivery device that provides for the controlled delivery of a beneficial agent in a hydrophilic carrier, followed by a continuous and sustained delivery of an agent in a controlled and uniform amount over a prolonged period of time. However, the dual rates are not programmable, but are rather controlled through the physical attributes of the device and osmotic pumping. The U.S. Pat. No. 5,240,713 further provides a comprehensive list of prior art relating to drug delivery devices.
What is needed is an implantable pump capable of independently delivering multiple medications at independently programmable rates.
The present invention addresses the above and other needs by providing an implantable pump system that includes: (1) an implantable pump having separate chambers or reservoirs, at least one of which is coupled to the pump so as to allow a programmable rate of delivery of the medication stored in the pump chamber or reservoir, the other chambers or reservoirs of which are at least capable of delivery a bolus via a pressurized, and potentially independently programmable chamber or pumping mechanism; (2) a patient controller that enables the actuation of the pump so as to administer a bolus or programmed rate of the first, second, third, . . . or nth medication contained in the independent chambers or reservoirs coupled to the pump; and (3) a catheter having two or more reservoir-specific inlet ports directed into respective lumens of the catheter.
In one embodiment, the distal tips of the respective lumens may be directed to different sites within the patient's body, thereby allowing site specific and independent delivery of the medications stored in the respective pump chambers or reservoirs to be administered to different body sites at independently controlled times and rates.
In another embodiment, the distal tips of the respective lumens are directed, more or less, to the same body site or tissue region, thereby providing for the independent delivery of multiple medications to the same regions at independently controlled times and rates.
Advantageously the medications administered through use of the implantable pump having multiple chambers and delivery lumens may comprise drugs, biologics, proteins, genetic materials, and any other substance or material which medical personnel may prescribe as being beneficial for the patient to receive.
An important feature of the present invention is the programmability of the pump, which allows different medications to be delivered through independent lumens at different times and rates. In one embodiment, such programming may be done electronically, based on a clock or different times of the day. In another embodiment, one or more body sensors are coupled with the pump and are adapted to sense various physiological parameters, such as muscle tone, heart rate, respiration rate, blood oxygen saturation, physical activity, temperature, glucose level, and the like. In accordance with the use of such sensor(s), when certain physiological conditions are sensed by the sensor(s), the pump is actuated so as to deliver a programmed amount of one or more medications selected as a function of the sensed physiological condition. For example, if a sudden, fast heart rate is sensed, an appropriate medication may be administered in an attempt to slow the heart rate.
It is thus a feature of the present invention to provide an a multi-chamber programmable, implantable pump.
It is a further feature of the invention to provide a multi-lumen catheter for use with such pump through which multiple medications may be independently delivered by the pump.
The above and other aspects, features and advantages of the present invention will be more apparent from the following more particular description thereof, presented in conjunction with the following drawings wherein:
Corresponding reference characters indicate corresponding components throughout the several views of the drawings.
The following description is of the best mode presently contemplated for carrying out the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of describing the general principles of the invention. The scope of the invention should be determined with reference to the claims.
Turning first to
The multi-lumen catheter 14 includes a multiplicity of independent lumens therein, each terminating at a distal tip 16. For the embodiment shown in
Advantageously, each medication delivered through the multi-lumen catheter 14 may be delivered at its own programmed rate and/or start/stop time. The medications administered through the delivery lumens 16 a, 16 b, 16 c, . . . may comprise drugs, biologics, proteins, genetic materials, and any other substance or material which medical personnel may prescribe as being beneficial for the patient to receive.
Programming or control of the implantable pump 12 shown in
Additionally, at least in some embodiments of the invention, the implantable pump 12 sends status signals, e.g., back-telemetry signals, to the remote control unit 20 through the telecommunications link 22. Such status signals provide information to the remote user, by way of a display included on, or coupled to, the remote unit 20 relative to the performance and status of the pump 20. Such back-telemetry data indicates, e.g., the state of charge of a battery included as part of the pump, the amount of medication remaining in its multiple reservoirs or chambers, the amount of medication that has been delivered through a given lumen of the catheter during a specified time period, and the like. Back telemetry may also be used, when sensors 18 are employed with the device, e.g., as shown in
Next, as seen in
Additionally, unlike the system 10 of
The types of physiological parameters that may be sensed by the sensors 18 a, 18 b, . . . 18 m include, but are not necessarily limited to, muscle tone, heart rate, respiration rate, blood oxygen saturation, tissue impedance, physical activity, body position (e.g., lying, sitting or standing), body temperature, glucose level, and the like. As has been indicated, signals representative of the physiological parameters sensed by the sensors 18 a, 18 b, 18 c, . . . 18 m may be telemetered to an external device, e.g., to the remote programmer 20, for storage, display, or analysis.
Turning next to
As seen in
Each chamber 30 a, 30 b, . . . 30 n has a pump mechanism associated therewith that causes the medication stored in the respective chamber to be dispensed through the respective lumen at a programmed rate and/or at a programmed delivery time. By way of functional illustration only, the pump mechanism associated with chambers 30 a includes a miniature stepping motor M1 that drives a lead screw 37 passing through an anchored lead nut 35. A distal end of the lead screw 37 attaches to movable diaphragm 36, which diaphragm forms one wall of the chamber 30 a. As the lead screw 37 rotates a fixed rotational amount, under control of the stepper motor M1, the distal end of the lead screw, and hence the diaphragm 36, advances a fixed amount, causing a fixed volume of medication within chamber 30 a to be dispensed through lumen 17 a.
In a similar manner, additional miniature stepper motors M2, M3, . . . Mn, control respective lead screws coupled to movable diaphragms of chambers 30 b, 30 c, . . . 30 n, thereby allowing controlled volumes of medication stored in chambers 30 b, 30 c, . . . 30 n to be dispensed through lumens 17 b, 17 c, . . . 17 n, respectively.
The chambers 30 a, 30 b, 30 c, . . . 30 n may be realized using a balloon made from a suitable stretchable material, e.g., silicone rubber or Silastic, and the movable diaphragm 36 may be a wall or plunger that collapses against one side of the balloon, forcing the liquid contents of the balloon, i.e., the medication stored therein, to be dispensed through the respective lumen.
The stepper motors M1, M2, M3, . . . Mn are controlled by respective driver circuits contained within the pump control circuitry 34. Such control circuitry includes, in addition to the pump driver circuits, suitable logic circuitry for controlling operation of the pumps in accordance with programmed parameters. The logic circuitry may comprise a state machine and/or a microprocessor. The programmed parameters are stored in suitable memory circuitry, as is known in the art. The parameters that may be stored in the memory circuitry include, for each stepper motor or equivalent pump activation mechanism, dispense start time, dispense stop time, max dispensed volume, and rate.
Operating power for the pump control circuitry 34 and the stepper motors M1, M2, M3 . . . Mn is provided by a suitable battery 38. The battery 38 may be a primary Lithium Ion battery that has sufficient energy stored therein to power the operation of the pump control circuitry 34 for 3–10 years, or a rechargeable battery, e.g., a rechargeable Lithium Ion battery, as is known in the art.
A telemetry/recharge circuit 40 allows programming signals and recharge energy to be received from an external remote control/programmer unit 20 or an external charger unit 24. In one embodiment, the telemetry/recharge circuit 40 includes a coil that is inductively linked with another coil included within the remote control/programmer unit 20 or the remote charger 24. A carrier signal is coupled from the remote coil to the implanted coil. Energy contained within the carrier signal is used to recharge the battery 38. Control and/or programming data is transferred to the implantable unit 12 by modulating the carrier signal. Back-telemetry may occur in the same manner, but at a different frequency. Other forms of data/energy transfer may also be employed, as needed or as appropriate.
One or more physiological sensors 18 a, 18 b, 18 c, . . . 18 m may optionally be used with the implantable pump in order to provide physiological feedback to the pump control circuits in order to control the medication delivery in an appropriate manner. The use of such physiological sensors was described previously in connection with the description of
All of the components of the pump 12, except one or more of the optional sensors 18 a, 18 b, . . . 18 m, are housed in an implantable housing 31. The miniature stepper motors M1, M2 . . . Mn may be housed within a separate enclosure 33 included within the housing 31. The housing 31 is preferably of a size and shape that facilitates its implantation under the skin 15 of a patient. Typically, such shape will comprise a relatively flat case, having rounded corners, much like existing implantable pacemakers or cochlear stimulators.
An alternative embodiment of a multi-lumen catheter 14′ that may be used with the invention is illustrated in
Next, with reference to
As described above, it is thus seen that the present invention provides a multi-chamber programmable, implantable pump having a multi-lumen catheter through which multiple medications may be independently delivered to the same or different tissue locations by the pump.
While the invention herein disclosed has been described by means of specific embodiments and applications thereof, numerous modifications and variations could be made thereto by those skilled in the art without departing from the scope of the invention set forth in the claims.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4003379 *||Sep 24, 1975||Jan 18, 1977||Ellinwood Jr Everett H||Apparatus and method for implanted self-powered medication dispensing|
|US4072146 *||Sep 8, 1976||Feb 7, 1978||Howes Randolph M||Venous catheter device|
|US4373527||Apr 27, 1979||Feb 15, 1983||The Johns Hopkins University||Implantable, programmable medication infusion system|
|US4443218||Sep 9, 1982||Apr 17, 1984||Infusaid Corporation||Programmable implantable infusate pump|
|US4449983||Mar 22, 1982||May 22, 1984||Alza Corporation||Simultaneous delivery of two drugs from unit delivery device|
|US4588394||Mar 16, 1984||May 13, 1986||Pudenz-Schulte Medical Research Corp.||Infusion reservoir and pump system|
|US4634427||Sep 4, 1984||Jan 6, 1987||American Hospital Supply Company||Implantable demand medication delivery assembly|
|US4871351 *||Aug 26, 1987||Oct 3, 1989||Vladimir Feingold||Implantable medication infusion system|
|US4894057 *||Jun 19, 1987||Jan 16, 1990||Howes Randolph M||Flow enhanced multi-lumen venous catheter device|
|US5207642 *||Apr 28, 1989||May 4, 1993||Baxter International Inc.||Closed multi-fluid delivery system and method|
|US5240713||Sep 27, 1991||Aug 31, 1993||Alza Corporation||Dual rate agent delivery device|
|US5607393||Jun 6, 1995||Mar 4, 1997||Michigan Transtech Corporation||Implantable access devices|
|US5718678 *||Jun 26, 1996||Feb 17, 1998||Medical Components, Inc.||Multi-lumen coaxial catheter and method for making same|
|US6436091||Nov 16, 1999||Aug 20, 2002||Microsolutions, Inc.||Methods and implantable devices and systems for long term delivery of a pharmaceutical agent|
|US6471688 *||Feb 15, 2000||Oct 29, 2002||Microsolutions, Inc.||Osmotic pump drug delivery systems and methods|
|US6520936 *||Jun 8, 2000||Feb 18, 2003||Medtronic Minimed, Inc.||Method and apparatus for infusing liquids using a chemical reaction in an implanted infusion device|
|US6554822 *||Apr 28, 2000||Apr 29, 2003||University Of Southern California||Microbolus infusion pump|
|US6902544 *||Jan 22, 2003||Jun 7, 2005||Codman & Shurtleff, Inc.||Troubleshooting accelerator system for implantable drug delivery pumps|
|US20020188327||Apr 26, 2001||Dec 12, 2002||Chester Struble||Drug delivery for treatment of cardiac arrhythmia|
|WO2002072178A1||Mar 1, 2002||Sep 19, 2002||Medtronic, Inc.||Method and apparatus to control drug therapy dosages in an implantable pump|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8545477||Oct 22, 2008||Oct 1, 2013||Flowonix Medical Incorporated||Multiple reservoir implantable drug infusion device and method|
|US8551044||Mar 5, 2008||Oct 8, 2013||Flowonix Medical Incorporated||Multiple reservoir implantable drug infusion device and method|
|US8696633||Jun 15, 2011||Apr 15, 2014||Asante Solutions, Inc.||Operating an infusion pump system|
|US20090227989 *||Mar 5, 2008||Sep 10, 2009||Burke Paul F||Multiple reservoir implantable drug infusion device and method|
|US20100089487 *||Oct 22, 2008||Apr 15, 2010||Burke Paul F||Multiple reservoir implantable drug infusion device and method|
|WO2007119178A2 *||Jan 19, 2007||Oct 25, 2007||Neuren Pharmaceuticals Limited||Infusion pump|
|International Classification||A61M5/145, A61M31/00, A61M5/14, A61K9/22, A61M5/142, A61M5/168, A61M5/172|
|Cooperative Classification||A61M2005/1405, A61M5/1723, A61M5/16827, A61M5/1452, A61M2005/14208, A61M2205/3523, A61M5/14276, A61M2209/045|
|European Classification||A61M5/145B, A61M5/142P10|
|Jan 7, 2008||AS||Assignment|
Owner name: INFUSION SYSTEMS, LLC, CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BOSTON SCIENTIFIC NEUROMODULATION CORPORATION;REEL/FRAME:020329/0853
Effective date: 20080107
|Apr 14, 2008||AS||Assignment|
Owner name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION, CAL
Free format text: CHANGE OF NAME;ASSIGNOR:ADVANCED BIONICS CORPORATION;REEL/FRAME:020796/0264
Effective date: 20071116
|Sep 17, 2010||FPAY||Fee payment|
Year of fee payment: 4
|Apr 15, 2014||AS||Assignment|
Owner name: ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH,
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:INFUSION SYSTEMS, LLC;REEL/FRAME:032675/0148
Effective date: 20091229
|May 2, 2014||AS||Assignment|
Owner name: ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH,
Free format text: SECURITY INTEREST;ASSIGNOR:MEDALLION THERAPEUTICS, INC.;REEL/FRAME:032815/0188
Effective date: 20140331
|May 6, 2014||AS||Assignment|
Owner name: ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH,
Free format text: CORRECTIVE ASSIGNMENT TO CORRECT THE SCHEDULE WHICH REFLECTED PATENT NUMBER AS 8,327,041 AND SHOULDHAVE BEEN REFLECTED AS 8,372,041. PREVIOUSLY RECORDED ON REEL 032815 FRAME 0188. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST;ASSIGNOR:MEDALLION THERAPEUTICS, INC.;REEL/FRAME:032827/0478
Effective date: 20140331
|May 9, 2014||AS||Assignment|
Owner name: MEDALLION THERAPEUTICS, INC., CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH;REEL/FRAME:032892/0067
Effective date: 20140331
|Aug 12, 2014||FPAY||Fee payment|
Year of fee payment: 8